Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390722
Status:
WITHDRAWN
Last Update Posted:
2024-04-30
First Post:
2024-04-26
Brief Title:
A Study to Assess the Effect of Upadacitinib in Atopic Dermatitis-induced Sleep Disturbance in Adults With Moderate to Severe Atopic Dermatitis
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A Phase 3b4 Randomized Double-Blind Placebo-Controlled Study Evaluating the Effect of Upadacitinib on Atopic Dermatitis-induced Sleep Disturbance in Adults With Moderate to Severe Atopic Dermatitis SLEEP UP
Status:
WITHDRAWN
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
strategic decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Sleep Up
Brief Summary:
Many people with atopic dermatitis AD experience sleep disturbances Greater sleep disturbances are associated with greater burden including increased sick days and impaired cognition Patient focused research has found that sleep was one of the 3 most problematic symptoms for people with AD and their families
Upadacitinib demonstrated clinically meaningful sleep improvement based on patient-reported outcome measures such as the Atopic Dermatitis Impact Scale ADerm-IS Sleep Domain score in Phase 3 registrational trials but objective data on upadacitinibs effect on elements of sleep disturbance such as Wake After Sleep Onset or Sleep Efficiency have not been collected
Upadacitinib is an approved drug for the treatment of moderate to severe atopic dermatitis AD This study is conducted in 2 Periods During Period 1 participants are randomly assigned into 1 of 2 groups called treatment arms to receive upadacitinib or Placebo In Period 2 participants will be switched to receive open-label upadacitnib Approximately 112 adult participants ages 25 to 63 with moderate to severe AD who have moderate to severe sleep disturbance will be enrolled at up to 32 sites worldwide
This study consists of a 35-day Screening Period a 2-week randomized double-blinded period Period 1 a 22-week open-label extension period Period 2 and a 30-day follow-up visitcall Participants will receive oral tablets once per day of Upadacitinib or Placebo for 2 weeks followed by Upadacitinib oral tablet for 22 weeks
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the study at a hospital or clinic The effect of the treatment will be checked by medical assessments blood tests checking for side effects and completing questionnaires
Upadacitinib demonstrated clinically meaningful sleep improvement based on patient-reported outcome measures such as the Atopic Dermatitis Impact Scale ADerm-IS Sleep Domain score in Phase 3 registrational trials but objective data on upadacitinibs effect on elements of sleep disturbance such as Wake After Sleep Onset or Sleep Efficiency have not been collected
Upadacitinib is an approved drug for the treatment of moderate to severe atopic dermatitis AD This study is conducted in 2 Periods During Period 1 participants are randomly assigned into 1 of 2 groups called treatment arms to receive upadacitinib or Placebo In Period 2 participants will be switched to receive open-label upadacitnib Approximately 112 adult participants ages 25 to 63 with moderate to severe AD who have moderate to severe sleep disturbance will be enrolled at up to 32 sites worldwide
This study consists of a 35-day Screening Period a 2-week randomized double-blinded period Period 1 a 22-week open-label extension period Period 2 and a 30-day follow-up visitcall Participants will receive oral tablets once per day of Upadacitinib or Placebo for 2 weeks followed by Upadacitinib oral tablet for 22 weeks
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the study at a hospital or clinic The effect of the treatment will be checked by medical assessments blood tests checking for side effects and completing questionnaires
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None